In the last two years, theCenter for Disease Control and Prevention(CDC) has sent scientists and doctors into the field over 750 times to respond to health threats. Middle East Respiratory Syndrome (MERS), Ebola, and Avian flu are just a few of the diseases that have recently infiltrated large populations and required a global response to mitigate the risk.

In the event that there is a widespread public health outbreak, it's the responsibility of various government agencies, including the Department of Defense (DoD) and CDC, and commercial entities to sponsor research that will protect populations; ranging from the warfighter to the general public. Oftentimes these collaborations between government and industry facilitate vaccine development and distribution so that when an emergency arises they are prepared and can respond quickly.

In this blog we'll discuss three considerations when carrying out a large-scale vaccine distribution operation and the importance of a qualified deployment strategy.

Large-Scale Vaccine DistributionWhen a patient has been infected with a disease and needs medical attention, time is of the essence. It's impossible to respond quickly to a situation if you are not adequately prepared. Consider the following…

1. Importance of Inventory Management SystemSome forecasting may be done to anticipate the general potential of a public health threat. However, it is fairly difficult to determine the specific location, scale, or other identifiers associated with such an outbreak. While the amount of vaccine that is developed for storage prior to an outbreak is determined by the manufacturer, it's important to proactively monitor the vaccines and manage inventory in storage so that when the time comes you can react quickly. Oftentimes, dry-runs or exercises can help train for disaster mitigation and ensure everything runs smoothly in a stressful time. By being fully prepared, when vaccines are requested in a time of need it will be easier to execute the strategy, regardless of scale.

2. Experienced Transport Provider Outbreaks can occur anywhere, at anytime. The outbreak location may be in a rural area that is very difficult to get to and has little supporting infrastructure. Alternatively, it could also be in a densely populated area where the risk of infection spreading is very high. Here are some additional questions to consider when selecting a transportation provider:

- Is the treatment delivery point a secure site? The transportation provider must be able to avoid any barriers that may impede the recipient from receiving the treatment.

- Is the transportation provider qualified to provide vaccine transport services?Vaccines require appropriate handling in designated temperature conditions at all times with proper handling, tracking, and monitoring practices. One should consider auditing transport service provider's standard practices for compliance.

- Is the vaccine being shipped internationally? If so, some regions have restrictions in place and not all transport providers are authorized and/or willing to enter.

Regardless of the location, it's important to have an experienced partner that will be able to transport the vaccines to the outbreak location within the requested period of time.

3. Controlled Temperature Solution Throughout the storage and transportation processes, vaccines require effective temperature monitoring and control. Severalguidance documentshave been published that include very specific instructions surrounding vaccine storage and handling, as well as ways to determine that the cold chain has been maintained. For example, a monitoring device such as a vaccine vial monitor (VVM) may be considered. A VVM is a simple label containing a heat sensitive material that registers cumulative heat exposure over time. Small enough to place on every individual dose, the combined effects of time and temperature cause the inner square of the VVM to darken, gradually and irreversibly. A direct relationship exists between the rate of color change and temperature—the higher the temperature, the faster the color changes. VVMs give the end user visual confirmation, dose by dose, that the drug product is acceptable for use.

Qualified Deployment StrategyA qualified deployment strategy helps to ensure that the integrity of the vaccine is maintained throughout the chain of custody. This strategy goes beyond the items above (inventory management, transportation, temperature) and addresses other aspects such as training and SOPs. Employees must be properly trained in how to handle and package the material. Additionally, SOPs must be in place to provide additional guidance to employees in a comprehensive manner.

While many aspects of an outbreak are out of our control, it is possible to eliminate a public health threat through adequate preparation and by responding quickly. It's important to consider the items above when working towards the development of a large scale distribution strategy.

To learn more about how we've developed a qualified cold chain transport solution to transport vaccines to Uganda, download our Case Study below.